K243809
- 510(k) number
- K243809
- Device name
- Biolox® Delta Revision heads
- Applicant
- Limacorporate IT
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-03-04
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K243809.pdf
Official FDA record: K243809
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.